(Reuters) - The U.S. Centers for Medicare & Medicaid Services (CMS) on Friday proposed Medicare coverage of approved CAR-T cell therapies that use the patient’s immune system to fight cancer.

The proposal would require Medicare to cover the therapy nationwide when it is offered in a CMS-approved registry or clinical study, in which patients are monitored for at least two years post-treatment, CMS said.

The evidence from these studies and registries would help the agency identify the patients that benefit from CAR-T cell therapies.

“Today’s proposed coverage decision would improve access to this therapy while deepening CMS’s understanding of how patients in Medicare respond to it,” CMS Administrator Seema Verma said in a statement.

Chimeric antigen receptor T-cell therapy, known as CAR-T, harnesses the body’s own immune cells to recognize and attack malignant cells.

Gene therapy has come of age over the past few years. And Johnson & Johnson this morning gave its biggest signal yet that it wants in on the emerging field.

— xconomy new york. Ben Fidler. January 31, 2019

The deal comes at a time in which gene therapies have, at long last, made their way to the U.S. markets. In 2017, the FDA approved the first treatment to fix a faulty gene with a patient’s body— voretigene neparvovec (Luxturna), from Spark Therapeutics (NASDAQ: ONCE), for a rare form of inherited blindness. Another, known as Zolgensma, from Novartis (NYSE: NVS), could be approved in the U.S. this year, for the rare disease spinal muscular atrophy. And others are making clinical progress in blood diseases like hemophilia and beta-thalassemia, rare disorders such as Duchenne muscular dystrophy, and more. Two gene therapies were approved earlier in Europe.

These developments are the culmination of decades of scientific research on how to effectively and safely deliver genes to cells. Gene therapies shuttle DNA material into the body, typically with the help of an engineered virus, to help the body produce a critical protein—in perpetuity, theoretically. In hemophilia patients, for instance, experimental gene therapies help people make proteins that clot blood. Luxturna helps patients produce a protein that makes light receptors work in the eye.

With $100M MeiraGTx Deal, J&J Signals Bigger Move Into Gene Therapy

Good article from Xconomy site (Author: Ben Fidler) about J&J and field of gene therapy. You can read it HERE.

DV7™ Liquid Nitrogen Dewar Offers 7 Days Frozen Storage in a Compact, Non-palletized Form Factor Supporting Use on Regional Aircraft'

Phacilitate, Miami, January 2019: Team Savsu introduces two new models: the DV7 (temp range: -196c) and the ACS (temp range 2-8c). Interest in the new models was fantastic and, we want to thank everyone for stopping by to talk.

The evo ACS is a category-breaking 2-8°C shipper specifically designed for shipping apheresis collections of live cells intended for downstream manufacturing of autologous cell therapies. A smart system with thermal autonomy of 15+ days, the ACS allows cell therapy companies to safely source incoming materials globally while providing a high degree of supply chain control. Built for the challenges of commercialization, the ACS, connected to the evo.is, is "always on" and does not require special training or "button pushing" by hospital staff to turn the device on, as is the case with other shipping containers.

The ACS is a game changer. It gives our cell and gene therapy customers an unprecedented degree of flexibility in designing systems for their fresh cells that reduce risk, increase intelligence, and can scale through commercialization. With the current awareness of the impact variability of apheresis collections can have on final cell quality and therapeutic efficacy, we believe evo ACS will be very well received and preferred by the leading cell therapy developers.

— Bruce McCormick, President, Savsu Technologies

The new evo DV7 extends SAVSU's dry vapor shipper product line, which maintains biologic payloads at a temperature of -196°C during storage and transport. Positioned between the DV4 and the DV10, the DV7 offers 7 days of thermal autonomy in a compact unit, while maintaining a large payload size similar to the DV10. Like all other SAVSU DV shippers, the DV7 is built with SAVSU's proprietary Fusion Core™, Smart Cap™, and Autonomous Payload Extractor™ technologies.

Our customers have been asking for a compact evo DV shipper with 7 days of autonomy. The DV7 retains the advantages of the DV10 unit in a more compact form factor. It’s easier to handle, easier to store, and less expensive to ship. Since we design and build our evo shippers and evo.is cloud software, these new products represent our ability to respond to customer needs and quickly bring innovative products to market. Based on feedback from our early focus group customers, the DV7 could capture a significant share of the market for dry vapor shippers.

— Caitlin Rice, evo Product Manager, Savsu Technologies

Please contact us if you are interested in the DV7, ACS, or any of our products and services.

We will be exhibiting at Phacilitate Leader’s World & World Stem Cell Summit, January 22-25 in Miami. Savsu’s President, Bruce McCormick is giving a presentation on “Site Handling Challenges of Cryogenic Shippers” (see image for time and location)

Please contact us (directly or through the app) if you would like to set up a meeting while we are in Miami. Or stop by Booth 804 and chat.

Venue: Hyatt Regency, 400 South East Second Avenue, Miami, FL, 33131

Stay tuned! We will be making some exciting business and product announcements prior to the show.

National Cancer Institute \ Duncan Comprehensive Cancer Center at Baylor College of Medicine

An interesting, detailed article from Alex Lash at Xconomy reviewing the progress of the first two CAR-T therapies approved, Kymriah (from Novartis) and Yescarta (from Gilead Sciences). While the article may seem a bit negative, we think it simply reflects the normal difficulties of introducing a brand new, radically different, medical technology in to a complicated world.

A generation ago, cancer treatments made from a patient’s own living immune cells would have been science fiction. Now they’re here. The first two products, approved in 2017 and known in shorthand as CAR-T, have brought some people with otherwise untreatable blood cancers back from the brink of death.

The experimental results that led to approval for each product were remarkable. But outside the cautious, tightly controlled bubble of clinical studies, the products and their owners have had different experiences in the real world.

Nature happens … which is why we built the evo system! Snow and ice combination blew into Albuquerque yesterday (New Year’s Day). The city and Savsu are largely shut down today due to hazardous driving conditions. However, most of us are working on-line so, call and email like normal, and we can all pretend that we are in our offices. (We just aren’t shipping or receiving.)

Weather, customs, strikes, airport issues…there are a million reasons why your critical shipments might be delayed, or potentially delayed (just like today). The evo system keeps your payload thermally safe in these circumstances, lets all parties know exactly where your evo unit is and what the operating conditions are (internal and external), and allows our fantastic, specialty courier partners to show off their stuff (and maybe avoid the delay all together). So, Savsu’s headquarters may be closed today but, just like our evo system, our company is online and doing business.

Well its about 60 days late but, we are definitely moving in to our new digs this week! What does that mean?

First, our new address is:

4209 Balloon Park Rd. NE Albuquerque, NM 87109

Second, we are physically moving on Thursday and Friday of this week. We will be moving offices, computers, production equipment, inventory and switching over our data network on those days so, we are anticipating some communication issues. If you need to speak with us on Thursday or Friday, email and call and then be a little patient and we will get back to you when we get a signal.

Finally, our ability to ship will be very limited at the end of the week. Call our Customer Service team and let them know what you need this week and what can wait until next week.

We are very, very excited to relocate but, the actual move is going to be a little messy and there will be a few things still to finish after the move. Hang in there!

Very excited to be working with the great folks at Avexis on getting their important gene therapy to market using our evo system. Interesting application in our -80C range. Our patented VialRack technology dramatically improves performance of -80C shippers using a fraction of the dry ice. (-80 evos here).

ALBUQUERQUE, N.M., Nov. 5, 2018 /PRNewswire/ -- SAVSU Technologies, a leading developer and supplier of precision cloud-connected thermal shipping containers and the most advanced cold chain visibility platform ("SAVSU"), today announced that it is supplying its evo Smart Shipper and evo.is to AveXis, a gene therapy company developing treatments for patients suffering from rare and life-threatening neurological genetic diseases.

Privately held SAVSU Technologies is driving improved cold chain management of time and temperature cell and gene therapies through innovation and leveraged relationships with the leading specialty couriers serving the regenerative medicine market. BioLife Solutions (NASDAQ: BLFS), the leading supplier of biopreservation tools for regenerative medicine, holds a 44% equity ownership position in SAVSU.

We will be exhibiting at Phacilitate's Advanced Cell Therapy - Shanghai Summit October 29-31 in Shanghai, China. Massive interest in our evo system in China and across Southeast Asia, and this gives us a chance to meet some of those folks in person.

Please contact us if you would like to set up a meeting while we are in Shanghai.

Watershed moments occasionally come along in medical history when previously intractable or even deadly conditions suddenly become treatable or preventable. They are sometimes accompanied by a shift in how scientists understand the disorders in question.

We now seem to have reached such a threshold with certain rare autoimmune diseases of the brain. Not long ago, they could be a death sentence or warrant institutionalization. Now, with aggressive treatment directed at the immune system, patients can recover. Does this group encompass a larger chunk of psychiatric disorders? No one knows the answer yet, but it’s an exciting time to watch the question play out.

Just a fascinating article by Moises Velasquez-Manoff in the New York Times September 29, 2018 about an immune system link to mental health problems. We live in exciting times!

France’s CNIL agency said today that it’s received 3,767 complaints since May 25, when GDPR came into force, up from 2,294 complaints over the same period last year — which it notes was already a record year.

CNIL says this represents a 64% increase in complaints, which it suggests shows that EU citizens have “seized the GDPR strongly” — attributing public engagement on the issue to media attention on the new regulation and on data protection stories such as the Facebook-Cambridge Analytica data misuse scandal.

It also reports receiving more than 600 data breach notifications, affecting a total of around 15 million people, since GDPR D-Day.

Privacy, security, 21 CFR Part 11 compliance are all critical features in the software used in manufacturing of and logistics for cell and gene therapies. We have spent a lot of time and effort making our evo.is the best it can be in all these areas. Contact us to talk about our approach to satisfying these important, new, and complicated issues.

We will be attending Cell and Gene - Meeting On The Mesa in La Jolla, CA again this year. Meeting is October 3-5. Great opportunity to meet, talk and learn in a wonderful setting. Please reach out directly or, using the conference app, if you would like to set aside some time.

Very excited that United Airlines Cargo has accepted our evo® system into their TempControl and LifeGuard services. The evo system's unique dynamic performance and lean external packaging system open the evo to shipping on both narrow body and wide body aircraft, thus allowing shippers to take full advantage of United's extensive route system. We look forward to serving United's cargo customers.

CHICAGO, September 5, 2018– United Cargo today announced it will further enhance both its TempControl and LifeGuard services by accepting the evo®Cold Chain 2.0™ system developed by Savsu Technologies.

TempControl is United Cargo’s leading service for pharmaceuticals and other health care and life science material requiring temperature-controlled transport, and LifeGuard provides the carrier’s highest-priority same-day service for critically important medical shipments. The evo Cold Chain 2.0 is a fully integrated system designed specifically to provide comprehensive end-to-end transport protection and visibility for live cells used in biotechnology and precision medicine applications.

“The goal of expanding our customers’ options for packaging and transport systems is to ensure our services remain as relevant and valuable as possible,” said Jan Krems, President United Cargo. “Combining the elevated care and expedited priority of our TempControl and LifeGuard services with the proven thermal stability and dynamic data monitoring and visibilityof the evo Cold Chain 2.0 meets the needs of shippers of the most fragile and precious live material.”

“We are thrilled to participate in United Cargo’s TempControl and LifeGuard programs,” said Bruce McCormick, President Savsu Technologies. “The lean outer packaging of Savsu’s durable, high-performance shipping containers will optimize United’s network for advanced therapy and specialty courier clients by making transport available on both widebody and narrowbody aircraft.”

United Cargo customers seeking more information on the specifications and availability of the evo Cold Chain 2.0 system should visit https://www.savsu.com.

About SAVSU

SAVSU is a leading designer and manufacturer of innovative high-performance cloud-connected passive storage and transport containers for temperature sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials. For more information please visit www.savsu.com.

About United Cargo

United Cargo delivers superior shipping solutions via the cargo capacity of the world’s most comprehensive route network – approximately 4,600 flights a day to 357 airports operated by United Airlines and United Express. United operates a mainline fleet of 757 aircraft, including over 170 wide-bodies, on which United Cargo carried over 3 billion cargo ton miles in 2017. With U.S. mainland hubs in Chicago, Denver, Houston, Los Angeles, New York/Newark, San Francisco and Washington, D.C., and enhanced service to and from Asia and Australia, Europe, Latin America and the Middle East, United Cargo quickly transports customers’ shipments to and from virtually every major cargo market in the world. For more information, please visit unitedcargo.com.

Wow, what a busy day! The first day of Biotech Week - Boston, great news from United Air Cargo on evo product acceptance into their TempControl and LifeGuard services, and BioLife stepping up to make a big financial investment in Savsu. We have worked closely with the team at Biolife for years and admire their product, management talent and values. We appreciate their endorsement of our technology and our team at Savsu. Most importantly, BioLife's investment allows us to support the accelerating demand for our evo system in cell and gene therapy.

- Dana

Here is the press release issued this morning:

BioLife Solutions Increases Ownership in SAVSU Technologies to 44% with $5 Million Investment

Agreement Includes 18-Month Option to Acquire all SAVSU Outstanding Shares

BOTHELL, Washington— September 5, 2018 —BioLife Solutions, Inc. (NASDAQ: BLFS) (“BioLife”), the leading supplier of proprietary biopreservation media products for cell and gene therapies, today announced that it has increased its ownership of SAVSU Technologiesfrom approximately 31% to 44% with a $5 million investment. SAVSU will use the investment to scale up its operations and inventory to support increased demand for its evo®Dry Vapor Shippers and other precision temperature controlled shipping containers for cell and gene therapies.

The 18-month purchase option provides BioLife, at its sole discretion, with the right to acquire the 56% of SAVSU not already owned, for the greater of 1,000,000 shares of BioLife common stock, or approximately $23 million of BioLife common stock, calculated on the day of exercise. If BioLife exercises the purchase option in the future, 75% of the shares would be issued at closing, with the remaining 25% issued upon the achievement of specific revenue milestones.

Mike Rice, BioLife CEO, commented, “This additional investment in SAVSU supports our previously announced growth strategy to invest in companies and technologies that also supply the cell and gene therapy industry with innovative, highly valued solutions. We believe SAVSU is at an inflection point in product adoption in the cell and gene therapy market. The purchase option provides BioLife with complete flexibility with regard to a full acquisition of SAVSU, while setting a value today. Our decision to exercise the purchase option will be based on SAVSU’s continued revenue growth, and determining the optimal time to consolidate SAVSU and BioLife’s financial results.”

“We welcome this additional investment by BioLife as we grow our business,” stated Dana Barnard, SAVSU Technologies CEO. “SAVSU shippers and our evo cloud-based information system are currently being used by or in final evaluation with over 30 leading cell therapy companies. Along with these direct customers we are working closely with the world’s leading specialty logistics companies to provide seamless global distribution of the SAVSU shippers with real time information systems. SAVSU shippers can be used for both apheresis collections and manufactured cell therapies. Providing both inbound and outbound shipments on a single information platform, integrated with logistics partners and manufacturing sites, is our unique added value in the currently fragmented cold chain logistics paradigm.”

About BioLife Solutions

BioLife Solutions is the leading developer, manufacturer and supplier of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media for cells and tissues. Our proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the regenerative medicine, biobanking and drug discovery markets. Our biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death; offering commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function.

SAVSU is a privately held designer and manufacturer of innovative high-performance cloud-connected passive storage and transport containers for temperature sensitive biologics and pharmaceuticals. Our mission is to improve global health by greatly reducing the waste and risks associated with the improper freezing and overheating of thermal-sensitive medicines and biologics. SAVSU has developed proprietary state-of-the-art technology to ultimately lower costs and improve delivery of these most essential materials. For more information please visit www.savsu.com.

Cautions Regarding Forward Looking Statements

Except for historical information contained herein, this press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements concerning the company's anticipated future growth strategy, including the acquisition of synergistic cell and gene therapy manufacturing tools and services or technologies, the potential utility of and market for its products and services and potential revenue growth and market expansion. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Heading straight to London for Phacilitate: Leaders Europe 2018 following Boston Biotech Week conferences. Conference is September 11-12.

Bruce McCormick, President of Savsu, will be speaking on September 11 as part of the program on commercialization .

Please note that for this conference we will have a meeting room rather than a booth in the exhibit hall. Our room is: Willow 3 (1 level above the exhibition hall). We will have samples of our evo DV series units on display in the room.

We finally finished reading the whole thing and wanted to bring your attention to Module 2 (Summary of Quality Information), Section D (Product Handling At The Clinical Site). Please read the following excerpt from that document and, if you are uncertain how to comply, then call us (or stop by to see us at the upcoming shows in Boston and London).

Module 2. Summary of Quality InformationSection D. Product Handling at the Clinical Site

Proper control of the finished DP is critical to your investigational studies. Therefore, your IND should also include a description of how the product will be shipped to, received, and handled at the clinical site to ensure safety, product quality, and stability. Your IND should also include information on shipping conditions, storage conditions, expiration date/time (if applicable), and chain of custody from the manufacturer to the site of administration in the summary information of the CTD. Your summary in Module 2 should also include information for product handling at the clinical site prior to administration (such as thawing, washing, or the addition of diluent or adjuvant, loading into a delivery device, and transport to the bedside) and summary information on product stability prior to and during administration (e.g., in-device hold times and temperatures).

Our evo system (evo hardware + evo.is) currently supports the guidance advise relating to shipping condtions, storage conditions expiration date/time, chain of custody, and handling at the clinical site to the bedside.

We are proud to have lead the way in the awareness of these needs and to have developed a solution for these needs. Our system is IND ready!